FDAJuly 2, 2019device
Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes
What to do
FDA enforcement status: Terminated
Brands named
cincinnati sub zero products llc a genthermcincinnaticincinnati sub
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAFarm Rich Pizza Cheese Crunchers2026-05-19
- FDADairy House Ingredient Systems Strawberry Dairy Powder 05#5072-50, 50 lb bags2026-05-18
- FDALegacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags2026-05-18
- FDADairy House Ingredient Systems Vanilla Dairy Powder, 50 lb box2026-05-18
- FDAHydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T32026-04-24
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